Food Safety
Agencies' Handling of a Dioxin Incident Caused Hardships for Some Producers and Processors Gao ID: RCED-98-104 April 10, 1998In May 1997, the Environmental Protection Agency (EPA) discovered elevated levels of dioxin in poultry samples it analyzed as part of a reassessment of the health risks of dioxin. This discovery triggered a joint investigation by EPA, the Food Safety and Inspection Service (FSIS), and the Food and Drug Administration (FDA) to pinpoint the source of the contamination. The agencies traced the contamination to feed distributed to poultry, fish, hog, and cattle producers in several southern and southwestern states. At that point, FDA halted the distribution of the contaminated feed and requested that the feed be disposed of by those holding it. Later, FDA and FSIS required that the affected food products be tested to show that they did not contain elevated dioxin levels. By September 1997, FDA and FSIS had determined that all the food products derived from the animals that had eaten the contaminated feed had only background levels of dioxin and approved them for commercial distribution. However, large and small producers as well as state health officials questioned whether the levels at which dioxin was found in food warranted the action taken. Producers and state officials also reported that the agencies sometimes issued multiple and unclear directives, leading to confusion over the actions that producers were to take. This report determines (1) the basis for the federal agencies' decisions to require producers to demonstrate that their food products did not contain unacceptable levels of dioxin; (2) federal agencies' effectiveness in working together to make decisions to address the problem of dioxin-contaminated feed and in communicating their decisions to state agencies, producers, and processors; and (3) the impact of the food safety system on the handling of this dioxin incident.
GAO noted that: (1) the Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) requested the producers and processors to halt the distribution of food products with dioxin levels above one part per trillion because of their concern about the potential risk to human health that these products might present; (2) while scientists have not yet determined the level of dioxin that poses a danger to human health, FDA and FSIS believed that one part per trillion was an appropriate level to use for halting the distribution of these products; (3) FDA chose the one-part-per-trillion level to distinguish food products with elevated dioxin levels from those products with background dioxin levels; (4) the federal agencies worked cooperatively to identify the source of the dioxin contamination and to decide on the actions that might be necessary to address any health risks the contaminated food products posed to consumers; (5) however, their guidance to the affected producers and processors was sometimes unclear and impractical, which left the affected producers confused about the actions they needed to take; (6) for example, FDA, which is responsible for fish products, told producers they had to test their products, but the agency did not tell them how to collect their samples for testing; (7) in addition, the producers expressed concern that the agencies did not provide them with adequate time to comply with the agencies' testing requirements; (8) in some instances, the testing process took longer than the time allowed under the deadline; (9) although these regulatory actions delayed some food products from reaching the market, industry officials told GAO that FDA's and FSIS's actions did not result in the widespread destruction of affected food products; (10) in addressing the dioxin incident, the agencies involved had to overcome the inherent inefficiencies associated with the current food safety system, which divides responsibility for ensuring food safety among several agencies; and (11) as GAO has reported on numerous occasions, this fragmented food safety system necessitates extensive coordination efforts to minimize wasteful duplication of effort, prevent gaps in regulatory coverage, and avoid conflicting actions.